Kornimate/medical-research-clean huggingface dataset:
d-cycloserine augmentation of cognitive remediation in schizophrenia

Conditions: Schizophrenia

Summary: this study seeks to examine the effects of d-cycloserine augmentation on cognitive remediation for patients diagnosed with schizophrenia. we will test the hypotheses that d-cycloserine will significantly improve cognitive performance, negative symptoms, and measures of functioning compared to placebo when combined with eight weeks of cognitive remediation. we expect that these effects will persist when assessed at six-month follow up.

d-cycloserine has been shown to enhance learning in animal models and, in a previous trial, once-weekly d-cycloserine improved negative symptoms in schizophrenia subjects. we set out to test whether dcs combined with cognitive remediation would improve learning of a practiced auditory discrimination task and whether gains would generalize to unpracticed cognitive tasks. the proposed study consists of an 8-week, placebo-controlled, double-blind, parallel-group trial of d-cycloserine augmentation of cognitive remediation in schizophrenia outpatients. the primary outcome measure is change in performance on the matrics cognitive battery composite score after 8 weeks. secondary outcome measures include a measure of processing speed assessed after weeks 1, 2, 4 \& 8, and changes in negative symptoms and measures of functioning after 4 and 8 weeks. in addition, all outcome measures will be repeated at 6 months to assess persistence of benefit. hypotheses: 1. d-cycloserine will significantly improve cognitive performance as measured by the composite score on the matrics battery compared to placebo after 8 weeks of cognitive remediation. 2. d-cycloserine will significantly improve negative symptoms as measured by the sans compared to placebo after 8 weeks when combined with cognitive remediation. 3. d-cycloserine will significantly improve measures of functioning (gas, qol and cgi) at 8 weeks compared to placebo when combined with cognitive remediation. 4. d-cycloserine effects on cognition, negative symptoms and functioning will persist compared to placebo when assessed at 6-month follow-up.

Eligibility criteria:
inclusion criteria: * male or female * age 18-65 years * diagnosis of schizophrenia or schizoaffective disorder, depressed type * stable dose of antipsychotic for at least 4 weeks * able to provide informed consent * able to complete a cognitive battery * able to perform the cognitive remediation exercises exclusion criteria: * current treatment with clozapine * dementia * seizure disorder * unstable medical illness * renal insufficiency measured as egfr \>60mg/dl/min * active substance abuse: positive urine toxic screen * pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.

Keywords: cognitive impairment neuroplasticity d-cycloserine nmda anti-bacterial agents mental disorders psychotic disorders antitubercular agents schizophrenia and disorders with psychotic features schizoaffective disorder
ultrasound guided arterial puncture

Conditions: Arterial Puncture

Summary: the main purpose of the study is to evaluate whether the routine use of ultrasound guided arterial puncture can increase the proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis, when ultrasound guided arterial puncture is compared to conventional arterial puncture technique.


Eligibility criteria:
inclusion criteria: * patient admitted or treated in the acute emergency department * indication for a arterial blood gas analysis, according to the physician responsible for the patient's hospital stay / treatment exclusion criteria: * patient age \< 16 years
a study of ly900014 formulation in participants with type 1 diabetes mellitus using insulin pumps

Conditions: Diabetes Mellitus, Type 1

Summary: this study evaluated a blood sugar lowering insulin, ly900014, delivered by an insulin pump continuously under the skin. the study was conducted in participants with type 1 diabetes mellitus to investigate how the human body processed ly900014 and its effect on blood sugar levels when it was delivered via an insulin pump. side effects and tolerability were be documented.


Eligibility criteria:
inclusion criteria: * male or female participants with type 1 diabetes mellitus (t1dm) who are receiving insulin therapy via an approved insulin pump * have a body mass index (bmi) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening * have blood pressure, pulse rate, electrocardiogram (ecg), blood and urine laboratory test results that are acceptable for the study * have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party) * have venous access sufficient to allow for blood sampling * have provided written consent and are willing to follow study procedures and commit to the study duration exclusion criteria: * are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study * have previously participated or withdrawn from this study * have or used to have health problems, laboratory test results, blood pressure or ecg readings that, in the opinion of the doctor, could make it unsafe to participate in the study * had blood loss of more than 500 milliliters (ml) within the last month
to find out whether valsartan with or without other blood pressure medications would improve the ability of the heart to fill and empty, and the ability of the heart muscle to relax adequately in people with high blood pressure.

Conditions: Diastolic Dysfunction; Hypertension

Summary: patients who have had high blood pressure for a long time may have diastolic dysfunction. diastolic dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately. this study is to find out if valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.


Eligibility criteria:
inclusion criteria: * diagnosis/history of high blood pressure * male or female age 45 years or older exclusion criteria: * history of stroke, transient ischemic attack or heart attack within the last 6 months * a hospital admission for congestive heart failure within the last year * use of certain high blood pressure medications such as ace inhibitors, angiotensin receptor blockers or aldosterone antagonists or other agents that may work in the same pathway (raas) as valsartan within the past 3 months. other protocol-defined exclusion criteria may apply.

Keywords: hypertension, high blood pressure, diastolic dysfunction, heart disease
decitabine for chemotherapy unfit korean aml patients in real practice

Conditions: Acute Myeloid Leukemia; Elderly; Intensive Chemotherapy Unfit

Summary: prospective multicenter, open-lab el, observational, single arm study of decitabine. subjects will be elderly patients with newly diagnosed, treatment-naïve aml who are unfit to receive and not candidate for intensive induction chemotherapy (iic)


Eligibility criteria:
inclusion criteria: 1. newly diagnosed and therapy-naïve aml (bone marrow or peripheral blood blast counts ≥20%) 2. 65 years of age or older 3. taking informed consent with signature and date 4. not eligible for iic based on either: i) ≥75 years of age ii) comorbidity iii) secondary aml iv) poor performance (ecog ≥2) v) poor-risk by nccn guideline version 1.2015 vi) subject's choice (refusal for iic) investigator's judgement incompatible with iic exclusion criteria: 1. candidate for iic at the time of enrollment 2. promyelocytic leukemia, or aml with t(15;17) or pml/rarα rearrangement 3. aml with t(9;22) or bcr/abl rearrangement 4. leukemia central nervous system involvement 5. extramedullary myeloid sarcoma without bone marrow involvement 6. prior treatment with decitabine or azacitidine of any cause 7. any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine 8. second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy, or curatively resected non-melanoma skin cancer or intraepithelial cancer 9. premenopausal woman 10. severe active infection 11. uncontrolled bleeding hypersensitivity to decitabine
colchicine to prevent sympathetic denervation after an acute myocardial infarction

Conditions: Myocardial Infarction, Acute

Summary: this study evaluates the benefit of colchicine on induced denervation after myocardial infarction. patients who have suffered a documented de novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

cold-mi study aims to explore colchicine's impact on myocardial denervation following reperfused acute myocardial infarction. acute myocardial infarction is the leading cause of heart failure (hf). it induces myocardial denervation predisposing to ventricular rhythm disorders and death. this denervation linked to infarction's size occurs by direct ischaemic mechanisms during the initial coronary occlusion (initially non-vascularised zone) and secondarily by cardiac remodelling in the context of the heart failure (hf). in usual practice, cardiac denervation which intensity is correlated with rhythm and mortality risks, can be evaluated by scintigraphy. in a murine reperfusion model of ischemia, the direct anti-inflammatory effect of colchicine reduces the size of the necrosis and improves post-ischemic remodeling. this suggests that colchicine may reduce myocardial denervation.

Eligibility criteria:
inclusion criteria: * age from 18 to 80 year old * hospitalization within 12 hours of onset of acute chest pain * patient must have suffered a documented acute myocardial infarction * coronary occlusion on initial angiography (culprit artery with atimi (thrombolysis in myocardial infarction) flow 1 or 0) * patient eligible for a revascularization procedure by ptca (percutaneous transluminal coronary angioplasty) exclusion criteria: * patients with a history of myocardial infarction prior to the current episode * patient in cardiogenic shock or with hemodynamic instability * patients with severe hepatic or renal dysfunction (gfr ≤30 ml/min) * pregnant women or women of childbearing age without contraception * treatment with a potent cyp3a4 inhibitor or a p-glycoprotein inhibitor in patients with renal or hepatic impairement * association with macrolides (except spiramycin) * association with pristinamycin

Keywords: myocardial infarction sympathetic denervation heart failure
pharmacokinetics, safety, and tolerability of lumateperone long-acting injectable in patients with schizophrenia

Conditions: Schizophrenia

Summary: this is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. patients will be enrolled in one of up to four cohorts. all patients will receive oral lumateperone for 5 days, followed by a 5-day washout of oral lumateperone, then followed by a single dose of lumateperone lai.


Eligibility criteria:
key inclusion criteria: * male or female patients aged 18 to 50 years, inclusive * clinical diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to screening per investigator assessment * on a stable dose of antipsychotic medication, including lumateperone, for at least 3 months prior to the screening visit * clinical global impression - severity (cgi-s) score ≤ 3 key exclusion criteria: * clinically significant abnormality within 2 years of screening that, in the investigator's opinion, may place the patient at risk or interfere with study outcome variables * history of psychiatric condition other than schizophrenia that, in the investigator's opinion, may be detrimental to participation in the study * any suicidal ideation within the 6 months prior to screening, any suicidal behavior within 2 years prior to screening based on the columbia-suicide severity rating scale (c-ssrs) (excluding self-injurious, non-suicidal behavior), and/or investigator assessment that the patient is a safety risk to him/herself or others * surgical or medical condition (active or chronic) that in the investigator's opinion may interfere with drug absorption, distribution, metabolism, or excretion of the study drug or any other condition that may place the patient at risk; history of gastric bypass or sleeve gastrectomy; history of severe dystonic reaction on antipsychotics such as laryngeal spasm
thenar muscle ultrasound in cts evaluation

Conditions: Carpal Tunnel Syndrome

Summary: this study will include 20 patients aged 18-75 years who have been diagnosed with carpal tunnel syndrome (cts) based on electrophysiological examinations performed within the last three months, as well as 20 healthy volunteers without a cts diagnosis. sociodemographic data such as age, gender, height, weight, and bmi will be recorded. pinch grip strength will be evaluated using a jamar pinch meter, and hand grip strength will be assessed using a jamar dynamometer. ultrasound will be used to measure the cross-sectional area and thickness of the thenar muscles as well as the cross-sectional area of the median nerve. additionally, previous electrophysiological examination results will be recorded for the cts patients.


Eligibility criteria:
inclusion criteria: * patients aged 18-75 years. * diagnosed with carpal tunnel syndrome based on electrophysiological examination within the last 3 months. * healthy volunteers without a diagnosis of carpal tunnel syndrome. * volunteered to participate in the study. exclusion criteria: * refusal to participate in the study. * history of surgery due to carpal tunnel syndrome. * presence of neuromuscular diseases. * presence of advanced osteoarthritis. * presence of psychiatric disorders. * presence of cognitive impairments that may hinder study participation.
psychiatric disorders in children with psychogenic cough

Conditions: Psychogenic Cough

Summary: the study aims to evaluate psychiatric disorders and clinical features of children with psychogenic cough. psychiatric disorders are assessed via a semi-structured interview (kiddie schedule for affective disorders and schizophrenia) and clinical features are investigated via sociodemographic form, which was developped by researchers. investigator planned to compare psychiatric diagnoses, specifically anxiety and depression, with children referred to pediatric clinics.


Eligibility criteria:
inclusion criteria: * having psychogenic cough for study group. * referred to pediatric clinics. exclusion criteria: * chronical psychiatric disorder and pediatric disease history for control group.

Keywords: psychiatry, children, habit cough
extension study of ecu-mg-301 to evaluate safety and efficacy of eculizumab in refractory generalized myasthenia gravis

Conditions: Refractory Generalized Myasthenia Gravis

Summary: to evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gmg) as an extension study for the participants who previously completed study ecu-mg-301(nct01997229).

ecu-mg-302 was an extension study designed to provide the participants who completed study ecu-mg-301 an opportunity to receive eculizumab and collect clinical data to provide long-term safety and efficacy information on eculizumab in participants with refractory gmg. after receiving blinded study treatment (eculizumab or placebo) in study ecu-mg-301 for 26 weeks, participants were eligible to enroll in the ecu-mg-302 extension study. participants were to enter study ecu-mg-302 within 2 weeks after completing their week 26 visit in study ecu-mg-301. study ecu-mg-302 consisted of a 4-week blind induction phase to preserve the blinded nature of study ecu-mg-301, an open-label maintenance phase (up to 4 years), and a safety follow-up visit 8 weeks after the last dose for participants who withdrew from the study or discontinued eculizumab treatment at any time and for any reason after receiving any amount of eculizumab.

Eligibility criteria:
inclusion criteria: 1. participant has completed study ecu-mg-301. 2. participant has given written informed consent. 3. participant was willing and able to comply with the protocol requirements for the duration of the study. 4. female participant of childbearing potential must have had a negative pregnancy test (serum human chorionic gonadotropin). all participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment. exclusion criteria: 1. participants who withdrew from study ecu-mg-301 as a result of an adverse event related to study drug. 2. female participants who were pregnant, breastfeeding, or intended to conceive during the course of the study. 3. unresolved meningococcal infection 4. hypersensitivity to murine proteins or to one of the excipients of eculizumab 5. any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.

Keywords: gmg myasthenia gravis safety efficacy
omni study--assessing therapies in medtronic pacemaker, defibrillator, and cardiac resynchronization therapy devices.

Conditions: Tachycardia, Ventricular; Heart Failure, Congestive; Ventricular Fibrillation; Ventricular Dysfunction; Bradycardia

Summary: the purpose of the omni study is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe implantable cardioverter defibrillator(icd)therapy utilization for life threatening arrhythmias in primary and secondary prevention study participants. this study will assess therapies in medtronic pacemaker, defibrillator, and cardiac resynchronization therapy devices. the first therapy is for reducing unnecessary pacing in pacemaker patients. the second therapy provides pacing therapy in an attempt to stop fast or life threatening ventricular arrhythmias in lieu of delivering a defibrillation shock. the third therapy is a diagnostic measurement of a patient's fluid status and provides the physician information on the patient's heart failure status. the study will also assess the time to a patient's first defibrillation shock and will verify that the shock was for a fast or life threatening ventricular rhythm.

the omni results demonstrate the importance of medtronic's ongoing efforts to increase adoption of evidence based shock-reduction programming strategies. longer vf nid (number of intervals to detect in the vf zone) should be utilized with the anti-tachycardia pacing (atp) during charging feature. atp during charging allows physicians to treat with atp without delay to shock. therefore, vf nid may be extended to allow episodes the chance to self-terminate immediately to shock by use of the atp during the charging feature.

Eligibility criteria:
inclusion criteria: * implant of new or replacement study device. enrollment must occur no later than 40 days post-implant. * study participants must be 18 years of age or older. exclusion criteria: * study participants enrolled or intend to participate in another clinical device trial during the course of this study that required specific treatment or programming. * study participants unwilling and unable to comply with follow-up schedule.

Keywords: pacemaker defibrillator cardiac resynchronization dysynchrony heart failure arrhythmia tachycardia bradycardia
ceftobiprole in the treatment of pediatric patients with pneumonia

Conditions: Community-acquired Pneumonia (CAP); Hospital-acquired Pneumonia (HAP)

Summary: this was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (iv) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired bacterial pneumonia (hap) or community-acquired bacterial pneumonia (cap) requiring hospitalization, and requiring intravenous (iv) antibiotic therapy.

this was a randomized, investigator-blind, active-controlled multi-center study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole medocaril compared with iv standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients aged 3 months to less than 18 years with hap or cap requiring hospitalization and therapy with iv antibiotics. randomization was stratified by four age groups (3 months to \< 2 years; 2 years to \< 6 years; 6 years to \< 12 years; 12 years to \< 18 years), and by diagnosis of hap or cap.

Eligibility criteria:
inclusion criteria: * male of female aged 3 months to \< 18 years with a body weight of at least 5 kg * diagnosis of either hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalization and administration of iv antibiotic therapy * new or progressive imaging findings consistent with bacterial pneumonia * requirement for iv antibacterial treatment for pneumonia * other inclusion criteria may apply exclusion criteria: * known resistance of the causative pathogen to ceftobiprole or iv standard-of-care cephalosporin treatment (± vancomycin) * on mechanical ventilation * chest trauma with severe lung contusion or flail chest * acute respiratory distress syndrome * empyema or lung abscess * anatomical bronchial obstruction * active or currently treated pulmonary tuberculosis * atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or need for antibiotic coverage with a macrolide * pertussis, chemical pneumonitis, or cystic fibrosis * severe immunodeficiency * significant laboratory abnormalities including: hematocrit \ 5 times the age-specific upper limit of normal; * creatinine clearance \<50 ml/min/1.73 m² * use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization * history of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta lactam antibiotics or to vancomycin * poorly controlled seizure disorder * other exclusion criteria may apply